欧美药品注册制度比较研究

K. V. Priya, K. Umasankar, J. Kumar, M. Babu
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引用次数: 0

摘要

药品监管事务主要涉及不同药品的注册工艺参数和新药申请。法规事务专业人员在制药领域发挥着至关重要的作用,因为;它与保健产品有关。本文主要介绍美国和欧洲国家在药品注册方面的异同。它还提供了在医疗器械、药品、兽药、农药、化妆品和辅助药物、农用化学品等产品的安全、质量和功效方面保护公众健康的详细信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative study of medicinal products registration in USA and Europe
A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs professionals play vital roles in a pharmaceutical field as; it is related to healthcare products. The present article mainly focuses to provide similarities and differences in the registration of medicinal products in USA and European countries.This also provide details to protect public health in terms of safety, quality, and efficacy of products like medical devices, pharmaceuticals, veterinary medicines, pesticides, cosmetics & complementary medicines, agrochemicals, etc.
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